The invention concerns improvements in and relating to vertebral-column fusion devices, surgical apparatus and surgical methods. In particular, but not exclusively, the invention relates to a vertebral-column fusion device that is suitable to be received in an intervertebral space between two dorsal vertebrae, said fusion device comprising a curved strip of biocompatible material, with the width of the strip being such that after placement said strip makes contact with the aforementioned vertebrae.
Fusion devices aim to promote fusion of the adjoining vertebrae together. As such they are distinct from disc replacements where the new disc aims to mirror the behaviour of and to be given the mobility of the natural disc it replaces.
Fusion devices, in the most general sense, are known and are employed in cases where, as a result of accident, overloading, old age or otherwise, an intervertebral disc of the dorsal vertebral column is no longer able to perform its normal supporting and stabilising function. In these cases there is fitted in the space of said intervertebral disc a device which entirely or partially takes over the load-bearing function of the intervertebral disc until bone fusion has taken place. Known fusion devices of this type are constituted by a so-called cage construction with a closed peripheral surface which, for example, may have a cylindrical shape, and two end faces which after placement make contact with the two vertebrae bounding the intervening space. This type of fusion device is introduced into the intervertebral space by means of a surgical intervention and is maneuvered into a precise position. Moreover, for good stability and satisfactory load-bearing capacity it is usually necessary to fit two of these devices in the intervertebral space, side by side, one on each side of the vertebral column.
One disadvantage of these known devices is that they are difficult to fit in the intervertebral space, fitment being effected by means of a labourious, time-consuming and therefore expensive surgical intervention, in the course of which a relatively large access opening has to be made, with destabilisation and local trauma as a consequence. In the case of a posterior approach this is effected, as a rule, on the left and/or right sides of the spinal cord and in either case results in a fairly serious intervention.
The invention has amongst its aims to provide a better device that is simpler to fit in the intervertebral space and that, while preserving the simplicity of fitting, can nevertheless have a larger and therefore more favourable bearing surface than the known devices. The invention has amongst its aims to provide advantageous surgical apparatus for introducing devices into an intervertebral space. The present invention has amongst its aims to provide an advantageous surgical method for introducing a fusion device into an intervertebral space and/or for using surgical apparatus.
According to a first aspect of the invention we provide an intervertebral fusion device, the device comprising an elongate element, the elongate element providing one or more upper load bearing surfaces and one or more lower load bearing surfaces, the upper and lower load bearing surfaces being vertically spaced from one another by the elongate element, the elongate element having a first state and a second state, the elongate element having a substantially linear configuration in the first state and a less linear configuration in the second state, the elongate element being capable of transition, at least once, from the second state to first state and being capable of transition, at least once, from the first state to the second state, the elongate element being of shape memory alloy.
Preferably the intervertebral fusion device promotes fusion of one vertebrae to an adjacent vertebrae with the device there between. Fusion may be promoted by the ingrowth of bone or other material. The fusion device may restrain movement of one vertebrae relative to the other vertebrae the fusion device contacts.
The elongate element may be a substantially planar element, for instance a strip or sheet.
The elongate element may have a non-rectilinear cross-section at one or more locations along its length. The non-rectilinear cross-section may be provided throughout the length. The non-rectilinear cross-section may be provided at a plurality of locations along the length, with a rectilinear cross-section being provided at a location between two or more of those locations, ideally between each of those non-rectilinear cross-sections. The non-rectilinear cross-section may provide an increased thickness portion at the upper edge/upper load bearing surface and/or at the lower edge/lower load bearing surface of the elongate element. The non-rectilinear cross-section may be of a linear C-shaped cross-section. The portions of the elongate element having a non-rectilinear cross-section may have the same profile in the first and second states. The portions of the elongate element between the non-rectilinear portions may flex and/or bend during the change from first to second state and/or vice-versa.
The elongate element may be a mesh. The elongate element may be continuous or may have one or more holes or apertures in it. The holes may be round and/or oval and/or triangular and/or diamond shaped.
The elongate element may have a linear upper load bearing surface or surfaces. The elongate element may have a discontinuous upper surface. One or more indentations may be provided in the upper load bearing surface. The elongate element may have a serrated upper load bearing surface or surfaces. The elongate element may have one or more protrusions or spikes provided on the upper load bearing surface or surfaces. The upper surface of the elongate element may be defined by one or more, preferably linear, load bearing surfaces interspaced by one or more indentations. The indentations may be triangular in shape. The upper load bearing surface or surfaces of the elongate element may be provided with one or more protrusions or teeth. The protrusions or teeth may have a triangular profile.
The elongate element may have a linear lower load bearing surface or surfaces. The elongate element may have a discontinuous lower surface. One or more indentations may be provided in the lower load bearing surface. The elongate element may have a serrated lower load bearing surface or surfaces. The elongate element may have one or more protrusions or spikes provided on the lower load bearing surface or surfaces. The lower surface of the elongate element may be defined by one or more, preferably linear, load bearing surfaces interspaced by one or more indentations. The indentations may be triangular in shape. The lower load bearing surface or surfaces of the elongate element may be provided with one or more protrusions or teeth. The protrusions or teeth may have a triangular profile.
The upper and lower load bearing surface and/or one or more of the upper and lower load bearing surfaces may be parallel to one another. The upper and lower load bearing surface and/or one or more of the upper and lower load bearing surfaces may be angled relative to one another. The angle between a projection of the upper load bearing surfaces and/or at least one of the upper load bearing surfaces and the lower load bearing surface and/or at least one of the lower load bearing surfaces may be 5xc2x0 to 15xc2x0, more preferably 7xc2x0 to 13xc2x0. More preferably the angle is 8xc2x0 to 12xc2x0, still more preferably 9xc2x0 to 11xc2x0 and ideally is 10xc2x0. One or both of the upper or lower load bearing surfaces may be non-perpendicular to the height of the elongate element.
The upper and/or lower load bearing surface or surfaces may contact and/or enter the vertebrae in use.
The vertical spacing of the upper and lower load bearing surface or surfaces may be between 7 mm and 20 mm, preferably between 8 mm and 17 mm and ideally between 9 mm and 15 mm. The maximum vertical spacing is preferably less than 22 mm, more preferably less than 19 mm and ideally less than 17 mm. The maximum vertical spacing is preferably provided at one or both ends of the elongate element, particularly when the device is introduced from the anterior side of the patient. The maximum vertical spacing is preferably provided within the middle portion of the elongate element, particularly when the device is introduced from the posterior side of the patient.
The minimum vertical spacing is preferably more than 4 mm, more preferably more than 5 mm and ideally more than 6 mm. The minimum vertical spacing is preferably provided at one or both ends of the elongate element, particularly when the device is introduced from the posterior side of the patient. The minimum vertical spacing is preferably provided within the middle portion of the elongate element, particularly when the device is introduced from the anterior side of the patient.
The first state may provide a linear configuration for the elongate element. The first state may provide a non-linear configuration, for instance a curve or waveform, for the elongate element. A non-linear configuration may mean one end of the elongate element being offset from a tangent to the other end by less than 5 mm, preferably less than 4 mm, more preferably less than 2 mm and ideally less than 1 mm. A non-linear configuration may mean one or more portions of the elongate element being disposed to one side or the other side, relative to a centre line of the elongate element. The one or more portions may be so disposed by one or curves, preferably alternating direction curves, ideally a waveform. The first state may provide a configuration in which one end of the elongate element is further, in a straight line, from the other end of the elongate element than any other component. The part of the elongate element intervening the two ends may be non-linear, for instance including one or more curves. A wave form consisting of alternating curves of opposing direction is particularly preferred.
The second state may provide a configuration in which at least a part of the elongate element is curved. The second state may provide a situation in which the entire length of the elongate element is curved. The curve may be of constant radius throughout the length of the elongate element. The curve may be a various radii over the length of the elongate element. The minimum radius is preferably at least 3 mm and more preferably 5 mm.
The second state may provide a configuration in which at least a part of the elongate element is curved and in which at least a part of the elongate element has a waveform and/or serpentine and/or wavy profile. The parts may be the same part of the elongate element. The curves forming the waveform may have a radius of less than 1 mm.
In the second state the elongate element may have a configuration which is a part circle and/or full circle and/or spiral and/or U-shape and/or a part oval and/or full oval. The ends of the elongate element may be touching or may be apart in the second state. One end of the elongate element may be tucked behind the other in the second state, touching or not touching
Preferably the elongate element is formed of a single piece of shape memory alloy.
The shape memory alloy is preferably an alloy of titanium, most preferably with nickel. The shape memory alloy may be an alloy of copper and zinc and/or aluminium. The shape memory alloy may be an alloy of iron and nickel. The shape memory alloy may be an alloy of copper, aluminium and nickel. The alloys may include other elements.
The transition from second state to first state is preferably provided in the warm state for the shape memory alloy. The transition from the first to second state is preferably provided in the warm state for the shape memory alloy. The elongate element may be brought into in the cold state, prior to or during insertion and/or be in the cold state after insertion, at least temporarily. The transition from first state to second state may be caused by the elongate element passing from the cold state to the warm state in the patient. The passage from cold state to warm state may be caused by body heat and/or external heating.
The transition from second to first state is preferably achieved by the application of stress to the elongate element. The transition from first to second state is preferably achieved by the removal of the application of stress to the elongate element.
The shape memory alloy preferably undergoes pseudo-plastic deformation during the transition from first to second state. The transition from first to second state preferably involves a strain of less than 10% for any part of the elongate element, more preferably the elongation is less than 8% for any part.
The elongate element preferably has a thickness, for instance perpendicular to the vertical in use, of less than 2 mm and more preferably of less than 1.5 mm. A thickness of between 1 mm and 1.5 mm is preferred.
The elongate element may have a constant thickness throughout its length and/or width. The elongate element may be provided with one or more reduced thickness portions. The reduced thickness portion or portions may be provided by recesses and/or notches and/or grooves in the elongate element. Preferably the surfaces defining the elongate element and feature defining the reduced thickness portion are connected by rounded surfaces. The reduced thickness portion may have an extent along the elongate element at that reduced thickness. The feature defining the reduced thickness portion may include a curved portion linking the elongate element at normal thickness to the elongate element at reduced thickness, with a further curve linking the reduced thickness to the normal thickness of the elongate element. Preferably the feature defining the reduced thickness portion is provided on the outside surface of the elongate element. The feature defining the reduced thickness portion preferably extends throughout the width of the elongate element. The features defining the reduced thickness portion may be regularly spaced along the length of the elongate element. The features defining the reduced thickness portion or portions may be irregularly spaced along the length of the elongate element. In particular, the features defining the reduced thickness portion may be preferentially provided in the portion of the elongate element which undergoes the greatest change, even the change, in profile between the first and second state. The features defining the reduced thickness portion may be less frequently provided or absent from the portion or portions of the elongate element undergoing least or no change in profile between the first and second state.
Where the elongate element includes one or more reduced thickness portions and/or one or more enhanced thickness portions, it is preferred that the elongate element have a minimum thickness, in the reduced thickness portions, of at least 0.4 mm. It is preferred that the elongate element has a maximum thickness, in the non-reduced thickness portions, or enhanced thickness portions of at most 3 mm.
The maximum extent of the elongate element, measured from any point to any other in a straight line, is preferably less than 50 mm, more preferably less than 40 mm and ideally less than 35 mm. The maximum extent of the elongate element, measured from any point to any other in a straight line, is preferably at least 7 mm, more preferably at least 10 mm and ideally at least 12 mm.
One or both ends, preferably only the trailing end during insertion, of the device may be provided with an engagement profile. the engagement profile is preferably used to link the device to a surgical instrument, particularly a surgical instrument for inserting the device. the engagement profile preferably provides an engagement with the instrument during insertion and/or removal and/or manipulation and/or advancement and/or retraction of the device.
The engagement profile preferably provides one or more surfaces, at least in part, facing away from the other end of the device. Such a surface may provide an abutment surface during insertion. The engagement profile preferably provides one or more surfaces, at least in part, facing the other end of the device. Such a surface may provide an abutment surface during retraction and/or manipulation.
The engagement profile may include a surface extending from the end of the device, a second surface extruding from the end of the device and a third surface linking the two. The third surface may be generally parallel to the end of the device. The first and second surfaces are preferably non-perpendicular to the end of the device and/or non-parallel to one another. The engagement profile may define a protruding dovetail from the end of the device, ideally defined by the first, second and third surfaces.
The engagement profile may include a recess in the device defined by a first surface extending into the device, a second surface extending into the device and a third surface linking the two. The third surface may be generally parallel to the end of the device. The first and second surfaces are preferably non-perpendicular to the end of the device and/or non-parallel to one another. The engagement profile may define a recessed dovetail, ideally defined by the first, second and third surfaces.
The invention may be a vertebral-column device/prosthesis, suitable to be received in an intervertebral space between two dorsal vertebrae, said prosthesis comprising a curved strip of biocompatible material and the width of said strip being such that after placement said strip makes contact with the aforementioned vertebrae, characterised in that the strip is manufactured from a material that can undergo great elastic deformations before permanent deformation arises, and the strip is curved in a shape in which the extremities are situated apart from one another and the radius of the bent parts and the thickness of the strip are chosen in such a way that when the strip is bent out into an approximately straight strip scarcely any permanent deformation arises, whereby the strip which has been bent out into an approximately straight strip is capable of being introduced into an intervertebral space where the strip assumes its original curved shape.
The strip may be manufactured from a shape memory alloy/memory material, such as an alloy of titanium and nickel, which can undergo great deformation before permanent deformation arises.
The curved strip may have a U-shape. The curved strip may have a circular shape. The curved strip may have a spiral shape. The strip may have an oval shape.
The strip may have a thickness of 1.5 mm and the curved parts of the strip exhibit a radius of at least 12.5 mm. Where the minimum thickness of the elongate element is less than 1.5 mm, for instance, less than 1 mm, the curved parts of the strip may exhibit a radius of at least 8 mm.
The strip may be provided with holes. The strip may have a gauze structure.
The strip may have provided on its sides with projections which after the strip has been fitted in the intervertebral space come into contact with the two vertebrae bounding said space and fix the strip with respect to them.
According to the invention the device exhibits the characteristic that the strip is manufactured from a material that can undergo great deformations before permanent deformation arises, and the strip is curved in a shape in which the extremities are situated apart from one another and the radius of the curved parts as well as the thickness of the strip are chosen in such a way that when the strip is bent out into an at least approximately straight strip scarcely any permanent deformation arises, in which case the strip which has been bent out into an approximately straight strip is capable of being introduced into an intervertebral space where the strip assumes its original curved shape.
The material of the strip may, moreover, be constituted by a shape memory alloy/memory material such as an alloy of titanium and nickel. Such a material has, besides its advantageous property that it delivers virtually constant force in the course of progressive deformation, the additional property that it can undergo very great deformations of up to 6% to 8% without the material deforming permanently.
In the case of the devices according to the invention, optimal use is made of the aforementioned properties by giving the strip such a curved shape that crosscut edges are obtained which form a bearing surface of the desired dimension for the vertebrae. Moreover, the curves of the strip are given a radius such that, given the thickness of the strip which arises when the strip is bent out into a straight strip, scarcely any or no permanent deformations arisexe2x80x94that is to say, the deformations remain below the order of 6% to 8% straight can easily be inserted via a narrow slit-shaped incision into the intervertebral space where the strip then reassumes its original curved shape. Because the curved strip can have crosscut faces of substantial dimension in comparison with the crosscut faces of known devices, with the device according to the invention it is possible to use only one device which provides satisfactory load-bearing strength and stability in an intervertebral space. In this way the fitting of the device becomes simpler, because only one small opening is necessary for the insertion, causing less trauma. Depending on circumstances, the strip according to the invention can be curved in a U-shape, a circular shape, a spiral shape, a rectangular shape or any other desired shape. Another favourable design of the device according to the invention exhibits the characteristic that the strip has a thickness of 1.5 mm and the curved parts exhibit a radius of at least 12.5 mm. In this way it is ensured that when the strip is bent out into an almost straight strip the deformation of the strip in the curved parts remains below 8%, so that no permanent deformation or scarcely any permanent deformation arises and the strip reassumes its original curved shape after its introduction into the intervertebral space.
In order to promote a successful ingrowth and accretion of bone, according to a further embodiment of the devices according to the invention the strip is provided with holes or the strip is designed in the form of a gauze.
In order to fix the device well in its place after fitment in the intervertebral space, according to a further embodiment the strip is provided on its sides with projections which come into contact with vertebrae bounding the space and consequently oppose a displacement with respect to them.
According to a third aspect of the invention we provide a method of surgery, the method including the acts of:
making an incision in the patient;
removing at least part of an intervertebral disc from the patient through the incision, thereby providing an intervertebral disc space; and
inserting a device into the intervertebral space;
the device comprising an elongate element, the elongate element providing one or more upper load bearing surfaces for a vertebrae and one or more lower load bearing surfaces for a vertebrae, the upper and lower load bearing surfaces being vertically spaced from one another by the elongate element, the elongate element having a first state prior to insertion and a second state after insertion, the elongate element having a substantially linear configuration in the first state and a less linear configuration in the second state, the elongate element undergoing transition, from the first state to the second state within the patient, the elongate element being of shape memory alloy.
The device may have any of the features, options or possibilities set out elsewhere in this document, including the first and/or second and/or sixth aspects of the invention.
The incision may be made anteriorally and/or posteriorally. Preferably the incision is less than 5 cm long, more preferably less than 3 cm long.
Preferably at least the nucleus pulposus is removed. The annulous fibrosis and/or vertebral end-plate may also be removed.
The device may be inserted using surgical apparatus. The surgical apparatus may be provided as detailed in the fourth and/or fifth aspects of the invention and/or as described elsewhere in this document.
Whilst only a single device may be inserted in the intervertebral space between any two vertebrae, a plurality of devices may be inserted. Two or more devices may be inserted into a position where they are alongside one another. Two or more devices may be inserted into a position where at least a part of one of the devices is enclosed by one of the other device""s and/or lies within the outline of one of the other device""s. Two or more devices may be inserted such that an opening defined between the two ends of one of the device""s is opposed by at least a part of another device. Bone graft material may be provided within the outline of one or more of the devices. Bone graft material may be provided between at least a portion of one device and at least a portion of another device.
In the method the end of the apparatus, particularly the end of the holding frame, may be inserted into the incision and ideally between the vertebrae. The apparatus is preferably inserted in one orientation and rotated to a second orientation after insertion. The second orientation may be between 70 and 110xc2x0 of the first. Preferably the end of the apparatus abuts the opposing vertebrae during rotation. Preferably continued rotation increase the separation of the opposing vertebrae. In this way easier access to the vertebral space may be gained.
The insertion of the device may cause the transition from first to second state, particularly where the restraining force is removed by insertion. The transition from first to second state may occur after insertion of the device, particularly where the transition is caused by the device passing from cold state to warm state. The passage of the device from cold to warm state is preferably at least in part be caused by warming due to the patient""s body heat. Additional heating for the device may be provided, particularly external heating. The temperature of the device may be raised to at least 40xc2x0 C. and ideally to between 40xc2x0 C. and 50xc2x0 C. by external heating.
The method may include the ingrowth of bone or other material to complete the fusion after insertion.
The method may include retraction of the device. The method may include manipulation of the device. Preferably manipulation and/or retraction and/or insertion are provided using surgical apparatus according to the fourth or fifth aspects of the invention and/or by means of a profile on the end of the device as provided in the second aspect of the invention.
The method may include retraction of the device into the apparatus. The method may include retraction of the device so as to cause the device to change from the second state into the first state. The method may include the retraction of the device into the surgical apparatus.
The present invention also relates to apparatus that is suitable for the insertion of a device as described above into an intervertebral space.
According to a fourth aspect of the invention we provide surgical apparatus for inserting a device into a patient, the apparatus including a holding frame for the device, a pushing element configured to enter the holding frame, at least one hand operated component, the hand operated component being indirectly or directly linked to the pushing element, operation of the hand operated component advancing the pushing element into the holding frame.
The device may be as described in the first and/or second aspect of the invention.
The holding frame preferably extends along an axis. The cross-section of the holding frame perpendicular to the axis is preferably constant. Preferably the holding frame has an axial extent greater than the device, particularly relative to the first state for the device mentioned above. The holding frame is preferably continuous. The holding frame may be tubular. The tubular form may have a circular cross-section, but preferably has a rectilinear cross-section. The rectilinear cross-section may be between 1 and 20% greater than the cross-section of the elongate element in the height direction. The rectilinear cross-section may be between 1 and 10% greater than the cross-section of the elongate element forming the device in the thickness direction. The holding frame may be between 1 and 25% longer than the device in the length direction.
The length direction for the device may be its elongate direction and/or longest dimension. The thickness direction for the device may be perpendicular to its elongate direction and/or its smallest dimension. The height direction for the device may be perpendicular to its elongate direction and/or its intermediate dimension of the three.
The holding frame may be sealed at one or both ends. Preferably the holding frame is sealed. The holding frame may be sealed by seals, preferably the pushing element breaks the seal when advanced in to the holding frame. Preferably the device breaks the seal when advanced out of the holding frame.
The holding frame is preferably detachable from the apparatus. The detachable holding frame may be fully sealed prior to use. Preferably the interior of such a holding frame is sterile prior to use. The detachable holding frame may be disposable or reusable.
The apparatus may have a body. The body may provide a mount for the holding frame and/or at least one hand operated component and/or pushing element.
The pushing element may have a cross-section substantially corresponding to the cross-section of the device and/or the holding frame.
The pushing element may be mounted on a rod, shaft or other elongate element, particularly one end thereof.
The pushing element may advance the device by abutting the device and/or by engaging the device.
The pushing element may be retractable. Preferably the pushing element engages the device and facilitates retraction thereof. The engagement for the device may be provided by a profile in the pushing element. The profile may be a recess, slot or aperture. Preferably the profile cooperates with a portion of corresponding profile on the device. Preferably the profile provides one or more abutments between the pushing element and the device during advancement and/or retraction and/or manipulation. The profile may correspond and/or cooperate with a device profile as defined in the second aspect of the invention.
The at least one hand operated component may be pivotally mounted on the apparatus body and/or on a protrusion therefrom. The protrusion may be hand held in use. The at least one hand operated component preferably abuts on a driving element when operated. The at least one hand operated component preferably advances the driving element towards the holding frame when operated. The driving element preferably advances the pushing element and/or a mounting therefore towards the holding frame when operated. The driving element may have an aperture through which the mounting for the pushing element passes. The driving element preferably catches on the mounting when advanced towards the holing frame. The driving element may be biassed away from the holding frame, for instance by a spring within the body. Preferably the driving element passes over the mounting when driven back away from the holding frame. The body may provide a restraining element. Preferably the restraining element resists movement of the pushing element and/or mounting therefore away from the holding frame. Preferably the restraining element is biassed, ideally by a spring, away from the holding frame. The restraining element may be attached to the spring. Preferably the restraining element allows free movement of the pushing element or mounting therefore towards the holding frame.
According to a fifth aspect of the invention we provide apparatus suitable for introduction of the prosthesis according to one or more of the preceding claims into an intervertebral space, characterised in that the apparatus comprises an elongated tubular body with a receiving space for a strip which has been bent out in elongated manner, said apparatus being further provided with means for exerting a force on said strip for pressing the strip out of the receiving space into an intervertebral space.
The apparatus may have receiving space has a rectangular shape in cross-section.
The apparatus may have the means for exerting a pressing-out force on said strip are constituted by a rod, one end of which is provided with a part which enters into contact with the strip, said rod being guided within a wall bounding the receiving space, said rod being displaceable in stepwise manner in the direction of the receiving space by means appropriate for this purpose and being arrested in the other direction by a blocking mechanism which is capable of being cleared after the strip has been introduced, after which the rod can be removed from the receiving space. In the invention said apparatus may comprise an elongated tubular body with a receiving space for a strip which has been bent out in elongated manner, said apparatus being further provided with means for exerting a force on said strip for pressing the strip out of the receiving space into an intervertebral space.
Moreover, according to a preferred embodiment the cross-section of the receiving space is rectangular and the means for pressing the strip out are designed in such a way that pressing-out proceeds in stepwise manner.
According to a sixth aspect of the invention we provide an intervertebral fusion device, the device comprising an elongate element, the elongate element providing one or more upper load bearing surfaces and one or more lower load bearing surfaces, the upper and lower load bearing surfaces being vertically spaced from one another by the elongate element, the elongate element having a first state and a second state, the elongate element having a substantially linear configuration in the first state and a less linear configuration in the second state, the elongate element being capable of transition, at least once, from the second state to first state and being capable of transition, at least once, from the first state to the second state, the elongate element being formed of a plurality of elongate components which at least in part extend alongside one another.
The elongate element may be provided with a plurality of elongate components which contact one another over at least a part, preferably all, of their length. The elongate components may correspond to one another in form. The elongate components may be of matching form. The elongate components may be equivalent to one another. Three, four or five elongate components may be provided. The elongate components may be in the form of a plurality of equivalently configured strips, adjacent strips being in contact with one another.
The elongate components are preferably connected together to form a single elongate element. The elongate components are preferably connected together at one end, particularly the end which is inserted first into the patient. The elongate components may be connected together by one or more fastenings. The elongate components may be joined together by one or more adhesive components.
This aspect of the invention may include for its device any of the features, options or possibilities set out elsewhere in this document.